Internal Pharmacovigilance Audits: Ensuring Regulatory Readiness

What Are Internal Pharmacovigilance Audits?

Before a regulatory audit occurs, conducting internal pharmacovigilance audits is an essential strategy for maintaining compliance and avoiding unexpected findings. Internal audits allow companies to self-assess their pharmacovigilance systems, identify potential risks, and correct issues before they become problematic during an official audit.

The Value of Internal Audits in Pharmacovigilance

1. Identifying Compliance Gaps: Internal audits help to assess whether your pharmacovigilance system is fully compliant with all relevant regulations. These audits are particularly useful for identifying gaps in case processing, adverse event reporting timelines, and documentation management.

2. Proactive Risk Management: By identifying weaknesses early, internal audits help reduce the risk of non-compliance during regulatory audits. Viltis’ internal audit services are designed to proactively address potential risks, ensuring your systems are compliant with evolving regulatory requirements.

3. Strengthening Processes: Regular internal audits provide opportunities to optimize processes for adverse event reporting, risk management, and safety data collection. This can lead to faster reporting, improved safety signal detection, and better overall compliance.

4. Staff Preparedness: Internal audits also assess how well-prepared your staff is for handling regulatory audits. This includes reviewing training records, testing their understanding of pharmacovigilance procedures, and ensuring that key personnel are ready to interact with auditors.

How Viltis Can Help with Internal Pharmacovigilance Audits

At Viltis, we offer internal pharmacovigilance audit services that follow a structured, risk-based approach to ensure comprehensive review and assessment of your drug safety systems. Our process includes:

• Audit Planning: We help you create a detailed audit plan that identifies high-risk areas within your pharmacovigilance processes.

• Compliance Checks: Our team assesses your compliance with global regulations, including FDA, EMA, and ICH guidelines, focusing on adverse event reporting, risk management plans, and ICSR management.

• Audit Report and CAPA Development: After the internal audit, we provide a detailed report outlining any findings and areas for improvement. We also assist with developing Corrective and Preventive Actions (CAPA) plans to address any identified issues.

Regular Internal Audits: A Pillar of Compliance

Regular internal pharmacovigilance audits are a vital part of maintaining a compliant pharmacovigilance system. By consistently reviewing your processes, you can ensure your organization is always audit-ready and avoid costly regulatory consequences.

By combining preparation for regulatory audits with regular internal audits, Viltis provides companies with the tools they need to remain compliant and successful in the complex world of pharmacovigilance. Let us help you navigate the challenges of pharmacovigilance audits and inspections with confidence.